FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.
FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.
An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of their potential hea...
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for their weight loss dr...
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include adults with essentia...
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
